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SASInstitute A00-282 Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Validate Clinical Trial Data Reporting | 20% | - Validation principles - Programming validation techniques - Use PROC COMPARE and log review |
| Transform or Summarize Clinical Trials Data | 15% | - Aggregation and transposition - Derive variables and study days - Data step manipulation |
| Clinical Trials Data Structures | 10% | - CDISC standards: SDTM, ADaM - Clinical domain structures - Define.xml and dataset specifications |
| Regulatory Submissions | 5% | - ICH and FDA guidelines - Compliance for clinical data reporting |
| Apply Statistical Procedures for Clinical Trials | 15% | - Basic statistical analysis for clinical data - PROC MEANS, FREQ, TABULATE |
| Macro Programming for Clinical Trials | 15% | - Create and call macros - Macro variables and parameters - Debugging macros |
| Manage Clinical Trials Data | 5% | - Clean, merge, and subset data - Access and explore clinical datasets - Use SQL and dictionary tables |
| Clinical Trials Process | 5% | - Clinical trial lifecycle and protocol - Derive programming requirements from protocol and CRF |
| Report Clinical Trials Results | 10% | - Produce tables, listings, and figures - PROC REPORT and PROC PRINT |
SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:
Question 1
In a Statistical Analysis Plan (SAP) the following statement is written:
To test the association between the pain intensity reported by the patient and the treatment the patient has been administered, a Cochran-Mantel-Haenszel test will be performed adjusting for the country of the patient's investigational site.
The following variables and levels are used:
- Pain intensity (PAIN): "No pain", "Mild pain", "Moderate pain", "Severe pain", "Most severe pain"
- Treatment group (TREAT): "Placebo", "Drug A", "Drug B"
- Country (COUNTRY): Eight different values.
The following program is written to perform this analysis:
proc freq data=pain;
by COUNTRY;
tables PAIN * TREAT / cmh;
run;
This code does not produce the analysis requested by the SAP.
What is wrong with this code?
A. The variable PAIN should be on the BY statement along with the variable COUNTRY.
B. The option CMH should be on the PROC FREQ statement instead of on the TABLES statement.
C. The variables PAIN and TREAT should be on the BY statement, and the variable COUNTRY should be on the TABLES statement.
D. The variable COUNTRY should be on the TABLES statement instead of the BY statement.
Question 2
The following SAS program is submitted:
If the value for the variable Subjcode is "WGT2", what is the value of the variable Description?
A. Wgt2
B. Over
C. missing character value
D. Unknown
Question 3
A report that you are working on will require the following header lines:
Which code adds the second line of the header "Adverse Events"?
A. title2 'Adverse Events';
B. title2 = 'Adverse Events';
C. header2 'Adverse Events';
D. header2 = 'Adverse Events';
Question 4
Which statement correctly creates a SAS date variable from a character variable?
A. sasdate = 'chardate'd;
B. sasdate = input(chardate,date9.);
C. sasdate = date(chardate,date9.);
D. sasdate = put(chardate,date9.);
Question 5
The table below shows a subset of values of the variables LLTERM and HLTERM from a larger data set that is to be read into a DATA step.
Which subsetting IF statement could ensure that only records that have a missing value of LLTERM or a missing value of HLTERM are written to the resulting data set?
A. if cmiss(LLTERM, HLTERM) > 0;
B. if missing(LLTERM, HLTERM) > 0;
C. if anyalpha(LLTERM, HLTERM) > 0;
D. if nmiss(LLTERM, HLTERM) > 0;
Solutions:
| Question 1 Answer: D | Question 2 Answer: D | Question 3 Answer: A | Question 4 Answer: B | Question 5 Answer: A |






